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Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions).
JACC Cardiovasc Interv 2013; 6(9):914-22JC

Abstract

OBJECTIVES

This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes.

BACKGROUND

Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up.

METHODS

We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis.

RESULTS

At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other).

CONCLUSIONS

In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel.

Authors+Show Affiliations

Division of Cardiology, Mount Sinai Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: gdangas@crf.org.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24050859

Citation

Dangas, George D., et al. "Meta-analysis of Everolimus-eluting Versus Paclitaxel-eluting Stents in Coronary Artery Disease: Final 3-year Results of the SPIRIT Clinical Trials Program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)." JACC. Cardiovascular Interventions, vol. 6, no. 9, 2013, pp. 914-22.
Dangas GD, Serruys PW, Kereiakes DJ, et al. Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2013;6(9):914-22.
Dangas, G. D., Serruys, P. W., Kereiakes, D. J., Hermiller, J., Rizvi, A., Newman, W., ... Stone, G. W. (2013). Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC. Cardiovascular Interventions, 6(9), pp. 914-22. doi:10.1016/j.jcin.2013.05.005.
Dangas GD, et al. Meta-analysis of Everolimus-eluting Versus Paclitaxel-eluting Stents in Coronary Artery Disease: Final 3-year Results of the SPIRIT Clinical Trials Program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2013;6(9):914-22. PubMed PMID: 24050859.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). AU - Dangas,George D, AU - Serruys,Patrick W, AU - Kereiakes,Dean J, AU - Hermiller,James, AU - Rizvi,Ali, AU - Newman,William, AU - Sudhir,Krishnankutty, AU - Smith,Robert S,Jr AU - Cao,Sherry, AU - Theodoropoulos,Kleanthis, AU - Cutlip,Donald E, AU - Lansky,Alexandra J, AU - Stone,Gregg W, PY - 2013/05/03/received PY - 2013/05/09/accepted PY - 2013/9/21/entrez PY - 2013/9/21/pubmed PY - 2014/5/20/medline KW - EES KW - LAD KW - MACE KW - MI KW - PCI KW - PES KW - TLF KW - TLR KW - everolimus KW - everolimus-eluting stent(s) KW - left anterior descending KW - major adverse cardiac events KW - myocardial infarction KW - paclitaxel KW - paclitaxel-eluting stent(s) KW - percutaneous coronary intervention KW - restenosis KW - target lesion failure KW - target lesion revascularization SP - 914 EP - 22 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 6 IS - 9 N2 - OBJECTIVES: This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes. BACKGROUND: Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up. METHODS: We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis. RESULTS: At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other). CONCLUSIONS: In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel. SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/24050859/Meta_analysis_of_everolimus_eluting_versus_paclitaxel_eluting_stents_in_coronary_artery_disease:_final_3_year_results_of_the_SPIRIT_clinical_trials_program__Clinical_Evaluation_of_the_Xience_V_Everolimus_Eluting_Coronary_Stent_System_in_the_Treatment_of_Patients_With_De_Novo_Native_Coronary_Artery_Lesions__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(13)01099-6 DB - PRIME DP - Unbound Medicine ER -